RECRUITING

Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer

Conditions

Pancreatic Ductal Adenocarcinoma pembrolizumab pancreatic cancer pancreas adenocarcinoma folfirinox

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months

Official Title

Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

Quick Facts

Study Start:2022-08-31

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05132504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient is ≥18 years of age and has histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is potentially resectable. Patients with islet cell or other neuroendocrine neoplasms are excluded. 2. Definition of localized, potentially resectable disease: a) Adequate CT or MRI to determine staging and eligibility based on radiologic interpretation. b) No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein/portal vein (SMV/PV) with \< 180-degree abutment and no evidence of invasion. c) Clear fat plane between the SMA and celiac axis. d) No extension to celiac axis and hepatic artery. e) Patent superior mesenteric vein and portal vein. f) No evidence of distant metastatic disease 3. If a female patient is of childbearing potential, she must have a negative urine pregnancy test documented within 72 hours of first intervention. 4. Fertile participants must use contraception considered adequate and appropriate as stated in Appendix 3 (pages 61-62). 5. Male participants: A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period. 6. Patient must not have received prior chemotherapy or radiation for pancreatic cancer. 7. Patient has an ECOG performance status PS 0-1. 8. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form before participation in any study-related activities. 9. A female participant is eligible to participate if: 10. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 14 days before the start of interventions.	1. Patient has borderline resectable, locally advanced unresectable, or advanced metastatic disease. Patients with neuroendocrine tumors, adenosquamous cancer, lymphoma of the pancreas, or ampullary cancer are also ineligible. 2. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 3. Patient has known infection with HIV. 4. Patient has undergone major surgery, other than diagnostic surgery (-e.g. diagnostic laparoscopy or placement of a central venous catheter), within 4 weeks before registration. 5. Patient has a history of allergy or hypersensitivity to the study drugs. 6. Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 8. Patient has had clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before registration. 9. Patient is unwilling or unable to comply with study procedures. 10. Patient is enrolled in any other therapeutic clinical protocol or investigational trial. 11. Patients aged ≥ 80 are not excluded. However, candidates in this age group should be thoroughly evaluated before registration in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to. Patients should not be enrolled in the study should there be any hesitation on any of these considerations. Baseline criteria for all patients enrolled in the study must be carefully evaluated and all criteria followed appropriately. 12. Patient has evidence of peripheral neuropathy Grade 2 or higher. 13. A WOCBP who has a positive urine pregnancy test within 72 hours prior to first intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a second urine pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another urine pregnancy test must be performed and must be negative in order for the subject to start receiving study medication. 14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 15. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. 16. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 17. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 18. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. 19. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 20. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as detectable HCV by RNA) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authorities. 21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 23. Has had an allogenic tissue/solid organ transplant.

Inclusion Criteria

Exclusion Criteria

1. Patient is ≥18 years of age and has histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is potentially resectable. Patients with islet cell or other neuroendocrine neoplasms are excluded.
2. Definition of localized, potentially resectable disease: a) Adequate CT or MRI to determine staging and eligibility based on radiologic interpretation. b) No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein/portal vein (SMV/PV) with \< 180-degree abutment and no evidence of invasion. c) Clear fat plane between the SMA and celiac axis. d) No extension to celiac axis and hepatic artery. e) Patent superior mesenteric vein and portal vein. f) No evidence of distant metastatic disease 3. If a female patient is of childbearing potential, she must have a negative urine pregnancy test documented within 72 hours of first intervention. 4. Fertile participants must use contraception considered adequate and appropriate as stated in Appendix 3 (pages 61-62).
5. Male participants: A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.
6. Patient must not have received prior chemotherapy or radiation for pancreatic cancer. 7. Patient has an ECOG performance status PS 0-1. 8. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form before participation in any study-related activities.
9. A female participant is eligible to participate if:
10. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 14 days before the start of interventions.

1. Patient has borderline resectable, locally advanced unresectable, or advanced metastatic disease. Patients with neuroendocrine tumors, adenosquamous cancer, lymphoma of the pancreas, or ampullary cancer are also ineligible.
2. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
3. Patient has known infection with HIV.
4. Patient has undergone major surgery, other than diagnostic surgery (-e.g. diagnostic laparoscopy or placement of a central venous catheter), within 4 weeks before registration.
5. Patient has a history of allergy or hypersensitivity to the study drugs.
6. Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
8. Patient has had clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before registration.
9. Patient is unwilling or unable to comply with study procedures.
10. Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
11. Patients aged ≥ 80 are not excluded. However, candidates in this age group should be thoroughly evaluated before registration in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to. Patients should not be enrolled in the study should there be any hesitation on any of these considerations. Baseline criteria for all patients enrolled in the study must be carefully evaluated and all criteria followed appropriately.
12. Patient has evidence of peripheral neuropathy Grade 2 or higher.
13. A WOCBP who has a positive urine pregnancy test within 72 hours prior to first intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a second urine pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another urine pregnancy test must be performed and must be negative in order for the subject to start receiving study medication.
14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
15. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.
16. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
17. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
18. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
19. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
20. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as detectable HCV by RNA) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authorities.
21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
23. Has had an allogenic tissue/solid organ transplant.

Contacts and Locations

Study Contact

Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.

CONTACT

713-798-7828

Ramsay.camp@bcm.edu

Benjamin Musher, M.D.

CONTACT

713-798-4292

blmusher@bcm.edu

Principal Investigator

Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine

Houston, Texas, 77030

United States

Baylor St. Luke's Medical Center (BSLMC).

Houston, Texas, 77030

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Ernest R. Camp, M.D., M.S.C.R., F.A.C.S., PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-31

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-08-31

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

pembrolizumab
pancreatic cancer
pancreas adenocarcinoma
folfirinox

Additional Relevant MeSH Terms

Pancreatic Ductal Adenocarcinoma